FDA approves new indication for fibryga

The US subsidiary of Swiss family-owned protein specialist Octapharma today revealed that the US Food and Drug Administration (FDA) has expanded the approval of fibryga, fibrinogen (human) lyophilized powder for reconstitution, for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD).

The company noted that, as the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate option with this approval, fibryga represents a rapid and more precise option for severe bleeding scenarios than the current standard of care (cryoprecipitate).

Fibrinogen plays an important role in coagulation and blood clotting in emergency and surgical settings. Fibrinogen is the first coagulation factor to drop to critically low levels during severe bleeding episodes. Rapid replenishment of fibrinogen is essential for achieving hemostasis in bleeding patients.